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Venus ultrasound MR-TRUS AI fusion function assisted prostate biopsy: A prospective single-center cohort study

Venus ultrasound MR-TRUS AI fusion function assisted prostate biopsy: A prospective single-center cohort study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072960
Enrollment
Unknown
Registered
2023-06-28
Start date
2023-05-04
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

AI TB group /SB goup/AI TB +SB group:N/A

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Male, under the age of 80; 2) Meet any of the following criteria: a) Digital rectal examination (DRE) revealed suspicious nodules in the prostate, with any PSA values; b) PSA=10 µ g/L; c) 4 µ g/L=PSA<10 µ g/L, f/t PSA=0.16; 3) Suspicious lesions were found through mp-MRI, at least one lesion with PI-RADS = 3; 4) Good compliance, able to communicate well with researchers; 5) Volunteer to participate in the research and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Confirmed prostate cancer or acute prostatitis patients; 2) During the acute infection period, or clinical significance urinary tract infections; 3) Prostate biopsy performed within one month; 4) In the period of decompensation due to cardiac insufficiency; 5) Individuals with severe bleeding tendencies, or those who are unable to stop taking anticoagulants for a long time; 6) Severe internal hemorrhoids, external hemorrhoids, perianal or rectal lesions; 7) Patients with severe bone and joint diseases who cannot undergo lithotomy; 8) Having a hypertensive crisis; 9) Individuals who are unable to undergo anesthesia; 10) Those who suffer from mental illness or mental disorders and are unable to understand the informed consent form; 11) People who use electronic instruments such as built-in pacemakers, cochlear implants, and nerve stimulators; 12) Other contraindications to surgery, or those deemed unsuitable by the researcher to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Detection rate of cs-PCa;

Secondary

MeasureTime frame
Detection rate of any-PCa;

Countries

China

Contacts

Public ContactJie Zhu

Chinese PLA General Hospital

zhu_xiaocen@163.com+86 156 5270 6812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026